Implementation of ICH Q3D for Homoeopathic and Anthroposophic Medicinal Products

Rubrik: europharm

(Treffer aus pharmind, Nr. 06, Seite 808 (2017))

Linek M | Busch J | Lipinski A | Knödler M | Kühn M | Wollersen H | Noetel A | Steinhoff B

Implementation of ICH Q3D for Homoeopathic and Anthroposophic Medicinal Products / A Concept from Industry · Linek M, Busch J, Lipinski A, Knödler M, Kühn M, Wollersen H, Noetel A, Steinhoff B · ¹Weleda AG, Schwäbisch Gmünd und ²DHU-Arzneimittel GmbH & Co. KG, Karlsruhe und ³Homöopathisches Laboratorium A. Pflüger GmbH & Co. KG, Rheda-Wiedenbrück und ⁴WALA Heilmittel GmbH, Eckwälden/Bad Boll und ⁵Biologische Heilmittel Heel GmbH, Baden-Baden und ⁶Bundesverband der Arzneimittel-Hersteller e. V., Bonn
The new “ICH Guideline for Elemental Impurities” (ICH Q3D) [ 1 ] reached Step 4 of the ICH process in Dec 2014 and was recommended for adoption to the regulatory bodies of the European Union, Switzerland, Japan, USA and Canada (ICH = International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use). After final adoption by the Committee for Medicinal Products for Human Use (CHMP) in Dec 2014, the EMA published information on the transition periods in the European Union: New marketing authorisations for products containing new or established active substances should comply with the Guideline from ...

Manufacture of Homoeopathic Preparations

Rubrik: GMP / GLP / GCP

(Treffer aus pharmind, Nr. 03, Seite 388 (2014))

Lipinski A | Beck-Dreschel A | Wehausen R | Hering J | Orth H | Striebel P | Steinhoff B

Manufacture of Homoeopathic Preparations / Quality standards for raw materials and applicability of GMP requirements for the manufacture of homoeopathic preparations · Lipinski A, Beck-Dreschel A, Wehausen R, Hering J, Orth H, Striebel P, Steinhoff B · ¹ Homöopathisches Laboratorium A. Pflüger GmbH & Co. KG, Rheda-Wiedenbrück und Hevert-Arzneimittel GmbH & Co. KG, Nussbaum und Wala Heilmittel GmbH, Bad Boll und Weleda AG Heilmittelbetriebe, Schwäbisch Gmünd und DHU Arzneimittel GmbH & Co. KG, Karlsruhe und Biologische Heilmittel Heel GmbH, Baden-Baden und Bundesverband der Arzneimittel-Hersteller e. V. (BAH), Bonn (all in Germany)
Homoeopathic medicinal products are characterised by specific particularities. They contain one or more homoeopathic preparations as active substances/active pharmaceutical ingredients (API). They are produced from raw materials of natural or synthetic origin using specific homoeopathic manufacturing procedures, e. g. according to the European Pharmacopoeia or in the absence thereof to the German Homoeopathic Pharmacopoeia (HAB). This publication intends to demonstrate that for the different groups of raw materials used for the production of homoeopathic medicinal products, appropriate quality standards are followed. Furthermore it will be shown for which process steps GMP requirements are obligatory. Apart from the particularities of homoeopathy, Article ...